Ahmedabad, Gujarat, India (IN)FEI: 3015092811DUNS: 650918273Ophthalmic Drops, Nasal Sprays & OTC Monograph Drugs

Ahmedabad Sterile Ophthalmics & Pharma Ltd.

Raw CBP/OASIS Entity String: AHMEDABAD STERILE OPHTHALMICS & PHARMA LTD.

FSVP Lead Auditor Note: Contract manufacturer of preservative-free carboxymethylcellulose lubricating eye drops and isotonic nasal sprays. Placed on Import Alert 66-40 Red List following a 9-observation Form FDA 483 citing ISO 5 aseptic filling interventions and water-for-injection (WFI) biofilm excursions.

Primary US Port

Newark

Last FDA Inspection

2026-05-21

OAI (Official Action Indicated)

Detained Cargo Value

$387,500

Across 3 holds

Est. US Containers/Yr

~90 TEUs

CBP ACE Bill of Lading

Composite Procurement RiskCRITICAL_IMPORT_ALERT

100/ 100 Risk Score

5-Year Import Refusals:3

Active Warning Letters:1

FDA Enforcement Recalls:1

Red List — Import Alert 66-40 (cGMP Sterility Non-Conformity)

Shipment Held? Request 24h Legal Review

6-Month Port Detention vs. Cleared Entry Velocity (Newark)

Source: CBP ACE Manifest + FDA OASIS Refusal Feed

May 2026

4 Held4 Cleared

Hold Rate: 50%

Jun 2026

6 Held2 Cleared

Hold Rate: 75%

Jul 2026

5 Held1 Cleared

Hold Rate: 83%

Aug 2026

6 Held0 Cleared

Hold Rate: 100%

Sep 2026

5 Held1 Cleared

Hold Rate: 83%

Oct 2026

4 Held1 Cleared

Hold Rate: 80%

Dataset 1 of 3 • FDA OASIS Import Refusals

Historical Port Detentions & Refusal Dispositions (3)

Entry # & Date	Port	Detained Product & FDA Code	Charge Code & Import Alert	Cargo Value	Final CBP/FDA Disposition
E12-4581920-4 2026-09-08	Newark	Preservative-Free Lubricant Eye Drops 0.5% (30 Single-Use Vials) FDA Product Code: 66V	INSANITARY_CONDITIONS Import Alert 66-40	$215,000	Refused & Exported
E12-4401928-1 2026-06-19	Newark	Homeopathic Euphrasia Redness Relief Eye Drops (Unapproved OTC Claim) FDA Product Code: 66V	UNAPPROVED_NEW_DRUG Import Alert 66-41	$94,000	Destroyed Under CBP Supervision
M52-7410293-5 2026-02-11	Miami	Pediatric Hypertonic Xylitol Nasal Mist FDA Product Code: 62C	INSANITARY_CONDITIONS Import Alert 66-40	$78,500	Refused & Exported

Dataset 2 of 3 • CDER / CFSAN / CDRH Enforcement

FDA Warning Letters & Form 483 Citations (1)

WL-320-26-41 • Issued 2026-08-03Active / Open

CDER Office of Manufacturing Quality (OMQ)

Significant Violations of Current Good Manufacturing Practice (CGMP) for Finished Pharmaceuticals

Inadequate validation of aseptic blow-fill-seal (BFS) media fills, deficient smoke studies in Grade A laminar airflow hoods, and incomplete environmental microbial investigations.

21 CFR § 211.113(b)21 CFR § 211.42(c)(10)FD&C Act § 501(a)(2)(A)

Dataset 3 of 3 • RES Recall Enterprise System

5-Year US Market Recalls (1)

Recall #D-0318-2026 (2026-06-25)Class I

ClearSoothe Multi-Dose Artificial Tears Lubricant Drops (15mL)

Reason: Lack of assurance of sterility discovered during FDA foreign cGMP inspection.

Distribution Scope: 62,000 bottles nationwide

Plain-English Statutory Translation & Importer Action Plan

Cited FDA Charge Codes & Remediation Checklists for Ahmedabad Sterile Ophthalmics & Pharma Ltd.

INSANITARY_CONDITIONS (FD&C Act Section 402(a)(4) / 501(a)(2)(A))Form 766 Ineligible (Lab/Export)

Adulterated: Prepared, packed, or held under insanitary conditions whereby it may have become contaminated

An FDA foreign inspection (Form FDA 483) or cGMP audit found systemic facility sanitation failures, non-sterile ophthalmic/OTC water systems, or pest harborage.

Importer Remediation Checklist:

Obtain the overseas manufacturer's full Form FDA 483 Establishment Inspection Report (EIR) and CAPA response timeline.
Verify whether the facility has been placed on Import Alert 66-40 (cGMP Drug/OTC) or 99-39 before shipping additional containers.
Retain US FDA regulatory counsel to submit an independent cGMP verification audit and petition for removal from DWPE.

Typical Hold: 30–60+ calendar daysView Full INSANITARY_CONDITIONS Form 766 Playbook →

UNAPPROVED_NEW_DRUG (FD&C Act Section 505(a))Form FDA 766 Relabeling Eligible

Unapproved New Drug: Cosmetic or Supplement making therapeutic disease claims

The product (often a skincare serum, device, or dietary supplement) uses medical or disease-cure claims on its packaging or website without an approved NDA/ANDA.

Importer Remediation Checklist:

Audit all product box copy, package inserts, and linked Shopify/Amazon URLs for therapeutic verbs ('cures', 'treats inflammation', 'heals acne').
File an FDA Relabeling Application (Form FDA 766) if the violation is purely on physical packaging.
Verify active ingredients against OTC Monograph compliance requirements.

Typical Hold: 14–28 calendar daysView Full UNAPPROVED_NEW_DRUG Form 766 Playbook →

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Full 5-year OASIS refusal history for Ahmedabad Sterile Ophthalmics & Pharma Ltd. + category peers
21 CFR 1.505 Foreign Supplier Verification Program (FSVP) audit checklist tab

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Get an automated Slack/Webhook JSON payload and email alert within 15 minutes whenever FDA OASIS logs a new detention, Import Alert Red List addition, or Warning Letter for Ahmedabad Sterile Ophthalmics & Pharma Ltd. before you wire your 70% balance payment.

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Respond-By Deadline Priority Triage

Shipment Detained by FDA or Placed on Import Alert? Request Free 24h Detention Evaluation from Licensed US FDA Compliance Counsel

When FDA issues a Notice of FDA Action (Detention), importers typically have only 10 to 20 business days to file a Form FDA 766 relabeling application, submit an accredited private laboratory packet (PLAP), or petition for Import Alert Red List removal before CBP orders refusal and liquidated damages.

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US Port of Detention

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Primary Cited FDA Charge Code

Charge listed on your Notice of FDA Action.

Commercial Cargo Value at Risk

Determines Form 766 vs. PLAP economic viability.

Notice of FDA Action Summary & Respond-By Date (Optional)

Describe whether cargo is currently on hold in ITACS, whether private lab sampling has started, or if you need an Import Alert removal petition.

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Ahmedabad Sterile Ophthalmics & Pharma Ltd. Compliance FAQ

Is Ahmedabad Sterile Ophthalmics & Pharma Ltd. (FEI 3015092811) on an FDA Import Alert Red List?

Ahmedabad Sterile Ophthalmics & Pharma Ltd. currently carries a Composite FDA Risk Score of 100/100 (CRITICAL_IMPORT_ALERT) in DWPERadar records with status: Red List — Import Alert 66-40 (cGMP Sterility Non-Conformity). Primary US port of entry is Newark. Historical records are informational only and should be cross-checked on official FDA dashboards before CBP filing.

What are the main FDA Charge Codes cited against Ahmedabad Sterile Ophthalmics & Pharma Ltd.?

Across the 5-year OASIS refusal dataset, Ahmedabad Sterile Ophthalmics & Pharma Ltd. has been cited for INSANITARY_CONDITIONS, UNAPPROVED_NEW_DRUG. Importers should review the statutory remediation checklists and Form FDA 766 eligibility before filing CBP entry.